Adult Dosing

Steroid-responsive inflammatory ocular conditions

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Inflammatory conditions of the palpebral and bulbar conjunctiva

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Chronic anterior uveitis and corneal injury

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Risk of superficial ocular infection

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Pediatric Dosing

• Note: Safety and effectiveness in pediatric patients <2 yrs of age have not been established

Steroid-responsive inflammatory ocular conditions

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Inflammatory conditions of the palpebral and bulbar conjunctiva

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Chronic anterior uveitis and corneal injury

Ophthalmic solution

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

Risk of superficial ocular infection

• Instill 1-2 gtt into the conjunctival sac(s) q4-6 hrs; during the first 24-48 hrs, titrate the dose to 1-2 gtt q2 hrs

Ophthalmic ointment

• Apply 0.5 inch ribbon into the conjunctival sac(s) tid-qid

[Outline]

• Adult Dosing
• Pediatric Dosing

• Steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exist
• Inflammatory conditions of palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution of edema and inflammation
• Chronic anterior uveitis and corneal injury from chemical, radiation, thermal burns, or penetration of foreign bodies
• Used in combination with an anti-infective component when there is an increased risk of superficial ocular infection or when there is an expectation that potentially dangerous numbers of bacteria will be present in the eye

• Hypersensitivity to any of the ingredients of the product
• Viral diseases of the cornea and conjunctiva
• Epithelial herpes simplex keratitis (dendritic keratitis)
• Vaccinia and varicella infections
• Mycobacterial infection of the eye
• Fungal diseases of ocular structures

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• For topical ophthalmic use only; not for injection into the eye
• Sensitivity to topical applications may occur; if such reactions occur, discontinue use
• Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation; monitor IOP regularly if it is used for more than 10 days or longer
• Long-term use also may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Re-evaluate the patient if signs/symptoms fail to improve after 2 days
• Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation. In certain diseases causing thinning of the cornea or sclera, perforations may result with topical steroid use
• The initial prescription and its renewal should be made by physicians only following slit-lamp biomicroscopy and fluorescein staining, if indicated
• Prolonged use of corticosteroids may cause overgrowth of non-susceptible organisms, including fungi; if superinfection develops, initiate appropriate therapy
• Ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye
• Fungal infections of the cornea may develop coincidentally with prolonged use of topical steroids
• Therapy may cause cross-sensitivity to other aminoglycoside antibiotics; discontinue use if hypersensitivity develops and begin appropriate therapy. When this drug is used in combination with other systemic aminoglycoside antibiotics, monitor the patients for total serum concentration
• Ophthalmic ointment may retard corneal wound healing
• In cases of bacterial ocular infection, patients should be advised not to wear contact lenses

Caution: Use cautiously in

• Patients with a history of herpes simplex virus

Supplemental Patient Information

• Instruct patients not to touch the dropper tip to any surface in order to prevent contamination of the contents
• Advise patients not to wear contact lenses during the use of this product

Pregnancy Category:C

Breastfeeding: Safety unknown. Minimal systemic absorption, maternal use of ophthalmic tobramycin is unlikely to affect the breastfed infant. Topical dexamethasone has not been studied during breastfeeding. Short-term application is unlikely to pose a risk to the breastfed infant by passage into breast milk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 May 2011). As per manufacturer's data, systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Manufacturer advises caution during nursing.

• EENT: Eyelid pruritus, eyelid edema, conjunctival hyperemia, elevated IOP, posterior subcapsular cataract formation, defect in visual acuity, blurred vision, secondary ocular infection, fungal infections, glaucoma, delayed ocular wound healing, infrequent optic nerve damage, eye pain
• MISC: Hypersensitivity reactions

Dexamethasone

• Corticosteroid; suppresses inflammation and the normal immune response
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

Tobramycin

• Aminoglycoside; binds to bacterial 30S ribosomal sub-unit and inhibits bacterial protein synthesis
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Tobradex
• Tobradex ST

US Availability

dexamethasone/tobramycin (generic)

• OPTH SUSP: 0.1%/0.3%

Tobradex (dexamethasone/tobramycin)

• OPTH SUSP: 0.1%/0.3%
• OPTH OINT: 0.1%/0.3%

Tobradex ST(dexamethasone/tobramycin)

• OPTH SUSP: 0.05%/0.3%

Canadian Trade Name(s)

• Tobradex

Canadian Availability

Tobradex (dexamethasone/tobramycin)

• OPTH SUSP: 0.1%/0.3%
• OPTH OINT: 0.1%/0.3%

UK Trade Name(s)

• Tobradex

UK Availability

Tobradex (dexamethasone/tobramycin)

• OPTH SUSP: 0.1%/0.3%

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Ophthalmic Steroids With Anti-infectives

Infectious Disease

Ophthalmic Steroids With Anti-infectives

Ophthalmic

Ophthalmic Steroids With Anti-infectives

Pricing data from www.DrugStore.com in U.S.A.

• TobraDex 0.3-0.1 % SUSP [Bottle] (ALCON VISION)
  2.5 % = $67.56
  7.5 % = $174.34
• TobraDex 0.3-0.1 % OINT [Tube] (ALCON VISION)
  3.5 % = $143.74
  7 % = $287.48
• TobraDex 0.3-0.1 % SUSP [Bottle] (ALCON VISION)
  5 % = $123.18
  15 % = $349.92

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.